FDA.reportPublic FDA data

Power Dental U.S.A., Inc.

Primary DI
D943N5882
Brand
Power Dental U.S.A., Inc.
Company
Power Dental U.S.A. Inc.
Model
N5882
Catalog number
N5882
Device description
ORTHODONTIC, U15 / PLG 2.8 SERRATION
Published
2021-06-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
ECSPUSHER, BAND, ORTHODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECSPusher, Band, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D943N5882PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic metal band pusherA hand-held dental instrument intended to be used by an orthodontist for positioning and adapting orthodontic metal bands on teeth. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(815)363-8003info@mydentalusa.com

Regulatory Flags#

DUNS number
081305064
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D94320240Power Dental USA202420242021-06-20
D94341260Power Dental USA412641262021-06-20
D943ORCAA0Power Dental USAORCAAORCAA2021-06-20
D94367350Power Dental USA673567352021-06-20
D94367380Power Dental USA673867382021-06-20
D94367390Power Dental USA673967392021-06-20
D94367410Power Dental USA674167412021-06-20
D94367430Power Dental USA674367432021-06-20
D94367140Power Dental USA671467142021-06-20
D94367420Power Dental USA674267422021-06-20
D9436710E0Power Dental USA6710E6710E2021-07-13
D94367310Power Dental USA673167312021-06-20
D94367320Power Dental USA673267322021-06-20
D94367150Power Dental USA671567152021-06-20
D9436716Power Dental USA671667162021-06-20
D9436733Power Dental USA673367332021-06-20
D9436734Power Dental USA673467342021-06-20
D9436740Power Dental USA674067402021-06-20
D9436750Power Dental USA675067502022-01-08
D9431007E0Power Dental USA1007E1007E2021-07-13

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Primary DI, Brand, Company table
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00840018662155Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCECS2026-01-29
00190707193317Ortho Technology®Ortho Organizers, Inc.ECS2025-10-23
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00190707193331Ortho Technology®Ortho Organizers, Inc.ECS2025-10-23
00190707193348Ortho Technology®Ortho Organizers, Inc.ECS2025-10-23
00190707193355Ortho Technology®Ortho Organizers, Inc.ECS2025-10-23
00190707193362Ortho Technology®Ortho Organizers, Inc.ECS2025-10-23
00190707193379Ortho Technology®Ortho Organizers, Inc.ECS2025-10-23
00190707193386Ortho Technology®Ortho Organizers, Inc.ECS2025-10-23
00190707193393Ortho Technology®Ortho Organizers, Inc.ECS2025-10-23
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00371347019803Advance Dental ProductsThe Atlanta Dental Supply CompanyECS2025-10-02
00889813066041Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCECS2024-11-30
00850058951362Amtouch Aligner ChewiesAMERICAN MEDICAL & HOSPITAL SUPPLY CO., INC.ECS2024-10-08
00850058951379Amtouch Aligner ChewiesAMERICAN MEDICAL & HOSPITAL SUPPLY CO., INC.ECS2024-10-08
00885797097293SchweickhardtRmo, Inc.ECS2024-08-19
00840105223597ZOLL DENTALZoll-DentalECS2024-07-29
00843471151273Young SpecialtiesYoung Innovations, Inc.ECS2024-07-11
00843471151280Young SpecialtiesYoung Innovations, Inc.ECS2024-07-11
00843471151297Young SpecialtiesYoung Innovations, Inc.ECS2024-07-11
00843471151303Young SpecialtiesYoung Innovations, Inc.ECS2024-07-11
00843471151310Young SpecialtiesYoung Innovations, Inc.ECS2024-07-11
07908611206053ORTHOCHEWIEORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECS2024-02-27
08800075622747OSUNG MNDOSUNG MND Co., Ltd.ECS2024-02-19
07898506814176QuinelatoSchobell Industrial LtdaECS2023-07-05
10889950042646Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCECS2023-06-27
10889950083335Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCECS2023-06-27
10889950083373Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCECS2023-06-27